Over the past month, a petition asking the governor of
Minnesota to investigate a research scandal at the University of Minnesota has
been steadily gathering momentum. The scandal in question originated in 2004
with the suicide of Dan Markingson in an AstraZeneca-funded study of
antipsychotics. The petition to investigate the scandal is backed by a number
of high-profile supporters, among them Lancet editor Richard Horton,
former BMJ editor Richard Smith, three former editors of the New
England Journal of Medicine (Marcia Angell, Arnold Relman, and Jerome
Kassirer), Wellesley College historian Susan Reverby, who uncovered the
Guatemala syphilis studies, Hastings Center co-founder Daniel Callahan, and
over 200 scholars in bioethics, clinical research,
medical humanities, and related disciplines.

The petition also has a noticeable gap. Very few signers come from
the University of Minnesota. In fact, only two people from the Center for
Bioethics have signed: Leigh Turner and me. This is not because any faculty
member outside the Department of Psychiatry actually defends the ethics of the
study, at least as far as I can tell. What seems to bother people here is
speaking out about it. Very few faculty members are willing to register their
objections publicly.

Why not? Well, there are the obvious possibilities—fear, apathy,
self-interest, and so on. At least one person has told me she is unwilling to
sign because she doesn’t think the petition will succeed. But there may be a
more interesting explanation that I’d like to explore. For those who are
unfamiliar with the scandal, however, let me backtrack briefly and explain the
events in question. (You can read the longer version in Mother Jones magazine
and additional background in a Bioethics Forum post.)

In late 2003, Dr. Stephen Olson, the head of the schizophrenia
program at the University of Minnesota, recruited an acutely psychotic young
man named Dan Markingson into an AstraZeneca-funded research study of
antipsychotic drugs. Olson enrolled Dan despite the fact that he had been
repeatedly judged incapable of giving informed consent, despite the fact that
his mother objected to his participation, and despite the fact that Dan had
been placed under an involuntary commitment order that legally compelled him to
obey Olson’s recommendations. For months, Mary Weiss, Dan’s mother, tried
desperately to get her son out of the study, warning that his condition was
worsening and that he was in danger of committing suicide. Her warnings were
ignored. In May 2004 Dan stabbed himself to death with a box cutter so violently
that he nearly decapitated himself.

The research study itself was plagued by ethical problems: financial
incentives to keep subjects in the study as long as possible, conflicts of
interest for the investigators, an inexplicable gap in the exclusion criteria,
and a questionable scientific rationale. AstraZeneca was eventually forced to
pay $520 million in fraud penalties, and some of its misconduct was traced back to the University of Minnesota.

You might think that events this alarming would prompt a
university investigation. That is not what happened. Instead, the university blocked Mary’s efforts to get Dan’s medical
records, and when her lawsuit against the university was dismissed on grounds
of sovereign immunity, it filed a legal action against her, demanding $57,000
in legal costs. Even as evidence has accumulated suggesting a much larger
problem involving more psychiatric studies and more mistreated
subjects, the university has stonewalled every effort to get to the truth.

Why would faculty members remain silent about such an alarming
sequence of events? One possible reason is simply because they do not feel as
if the wrongdoing has anything to do with them. The University of Minnesota is
a vast institution; the scandal took place in a single department; if anyone is
to be blamed, it is the psychiatrists and the university administrators, not
them. Simply being a faculty member at the university does not implicate them
in the wrongdoing or give them any special obligation to fix it. In a phrase:
no guilt, hence no responsibility.

My view is somewhat different. These events have made me deeply
ashamed to be a part of the University of Minnesota, in the same way that I
feel ashamed to be a Southerner when I see video clips of Strom Thurmond’s
race-baiting speeches or photos of Alabama police dogs snapping at black civil
rights marchers. I think that what our psychiatrists did to Dan Markingson was
wrong in the deepest sense. It was exploitative, cruel, and corrupt. Almost as
disgraceful are the actions university officials have taken to cover it up and
protect the reputation of the university. The shame I feel comes from the fact
that I have worked at the University of Minnesota for 15 years. I have even
been a member of the IRB. For better or worse, my identity is bound up with the
institution.

These two different reactions—shame versus guilt—differ in important
ways. Shame is linked with honor; it is about losing the respect of others, and
by virtue of that, losing your self-respect. And honor often involves
collective identity. While we don’t usually feel guilty about the actions of
other people, we often do feel ashamed if those actions reflect on our own
identities. So, for example, you can feel ashamed at the actions of your
parents, your fellow Lutherans, or your physician colleagues—even if you feel
as if it would be unfair for anyone to blame you personally for their actions.

Shame, unlike guilt, involves the imagined gaze of other people.
As Ruth Benedict writes: "Shame is a reaction to other people’s criticism.
A man is shamed either by being openly ridiculed or by fantasying to himself
that he has been made ridiculous. In either case it is a potent sanction. But
it requires an audience or at least a man’s fantasy of an audience. Guilt does
not.”

In scandals, this imagined audience can produce very different,
even opposite, reactions. On the one hand, it is what leads many people to try
so hard to keep scandals secret. This impulse to cover up wrongdoing can be
toxic, as the Catholic Church has discovered. But it is also what leads
insiders to speak out publicly against a scandal. By speaking out, you show
that you are separating yourself from the wrongdoing in order to maintain your
honor and self-respect. You are saying to the world, “Do not think that I am a
part of this.”

Shame and honor may seem like old-fashioned ideas, but if you read
the comments left on the petition by University of Minnesota alumni, you cannot
help but be struck by their language. “How shameful for UMN, my alma mater.” “I
am a graduate of the University of Minnesota and want to be proud of my school,
but following this case has made me deeply ashamed.” “I am a University of
Minnesota alum, and I am ashamed of my alma mater right now.” “To call this
merely shameful would be wholly inadequate.” “Attended U of MN Medical School
and then U of MN Psychiatry residency – ashamed of the Psychiatry Department.” “I
am a graduate (CLA, 1981) and ashamed of the way the University continues to
handle this tragic case.” “The University's legal team should also be ashamed
of their behavior in further victimizing this family.”

Obviously, this shame is something I understand, or else I would
not be working so hard to raise awareness of the petition and convince others
to sign on. (You can sign the petition here.) I also believe that the
truth will eventually come out, and when that happens, there will be more than
enough shame to go around. The refusal to investigate will only make things
worse. As Jesse Ballenger writes on the petition, “As a faculty member at a
university (Penn State) now notorious for failing to investigate abuses, I find
the refusal of the University of Minnesota to confront this scandal sadly
familiar.”

Editor’s Note: Beacon Broadside’s editor, Jessie Bennett, is
one of the University of Minnesota alumni quoted above.

Carl Elliott is the author of White Coat, Black Hat: Adventures on the Dark Side of Medicine. Elliott is a professor at the Center for Bioethics at the University of Minnesota. His work has appeared in The New Yorker, Atlantic Monthly, the Believer, Slate, the London Review of Books, and theAmerican Prospect. His six previous books include Better Than Well, Prozac As a Way of Life, Rules of Insanity, and A Philosophical Disease.

Another spectacular winter morning in Dunedin, New Zealand. Clear blue sky, frost on the ground, lush green hills plunging into the South Pacific. It is hard to complain about the setting, still less about the kindness and decency of the inhabitants. It has been nearly 22 years since my wife and I first landed in Dunedin, in August of 1990, when I began a postdoctoral fellowship at the newly established Bioethics Centre at the University of Otago. I still wonder why we ever left.

It was an extraordinary time for bioethics in New Zealand. In 1990, the country was still reeling from the shock of a medical research scandal—the “unfortunate experiment” at the National Women’s Hospital in Auckland. In that study, which had begun in 1966 and continued for another two decades, Dr. Herbert Green, an obstetrician-gynecologist, deliberately withheld treatment of 160 women with abnormal cervical smears in an effort to prove his misguided hypothesis that the cervical abnormalities would not lead to cervical cancer. Green enrolled women in the study without their knowledge or consent. Three of Green’s colleagues at Auckland University, Bill McIndoe, Jock McLean, and Ron Jones, tried to put a halt to the experiment for years, but they were ignored until they published a 1984 article in Obstetrics and Gynecology showing that the untreated women were 25 times more likely to develop invasive cancer. According to the Cartright Inquiry, the governmental commission set up to investigate the scandal, this amounted to a total of approximately 40 women developing invasive cancer, many of whom died.

The Medical Council of New Zealand eventually brought disciplinary action against Green and his superior, Dr. Denis Bonham. While the charges against Green were dropped because of Green’s poor health, the Council found Bonham guilty of disgraceful conduct. More importantly, the results of the Cartwright Inquiry led to dramatic changes in the oversight of medical research in New Zealand—among them the establishment of regional ethics committees, the creation of an Office of Health and Disability Commissioner, a code of rights for health consumers, and the appointment of an independent patient advocate at Auckland Women’s Hospital. Many of my friends and colleagues at the University of Otago were involved in the Cartwright Inquiry and its aftermath, perhaps most notably Dr. Charlotte Paul, who served as a medical adviser.

Two decades later, it is hard for me to avoid contrasting the ”unfortunate experiment” in Auckland to the psychiatric research scandal at the University of Minnesota, where I work now. The circumstances surrounding the suicide of Dan Markingson in an AstraZeneca-sponsored clinical trial of Seroquel were very different from those in Auckland, yet they were no less shocking: a floridly psychotic young man under a commitment order, who had been repeatedly judged incompetent to make his own medical decisions, was coerced into a highly profitable, scientifically dubious clinical trial over the objections of his mother, whose desperate warnings were subsequently ignored until the young man finally stabbed himself to death.

The two scandals have some similarities. In both cases, the wrongdoing was brought to public attention not by regulators or oversight bodies, but by journalists. The “unfortunate experiment” in Auckland was brought to light by Sandra Coney and Phillida Bunkle in Metro magazine, while Paul Tosto and Jeremy Olson exposed the Markingson scandal in the St. Paul Pioneer Press. Also, in both cases, the scandals were symptomatic of deeper ethical pathology. At the National Women’s Hospital, medical students had been performing vaginal examinations on anesthetized women without their knowledge, and house staff had practiced inserting and removing IUDs on anesthetized women before their hysterectomies. At the University of Minnesota, administrators have repeatedly covered up or minimized questionable financial dealings and conflicts of interest, even in the face of sustained public scrutiny. (See this, this, this, this, and this.)

Most importantly, administrators at both institutions downplayed or ignored the warnings of their own faculty members. In late 2010, after my article about the Markingson case appeared in Mother Jones, several University of Minnesota faculty members and I wrote a public letter to the board of regents asking for an external investigation. In February 2011, when the regents refused our request, Dr. Aaron Friedman, the Dean of the Medical School and Vice-President for Health Sciences, sent an email to the faculty making it clear where he stood on the matter. “As a result of this case, our department of psychiatry has experienced significant scrutiny and withering criticism over the past five years, and through it all, the faculty of the department have performed remarkably well in fulfilling its mission,” Friedman wrote. He went on to praise the psychiatrists behind the trial in which Markingson died, Dr. Stephen Olson and Dr. Charles Schulz, and to voice his strong support for industry-funded research. As for the death of Markingson, Friedman wrote, “I see the Regents’ statement as the end of the University’s review of this specific patient’s case.”

Here is where the responses to the Markingson case and to the “unfortunate experiment” differ. In Auckland, the Metro article by Coney and Bunkle set off a national debate, and eventually, sweeping reforms. These reforms came about in part due to the refusal of many New Zealand academics, physicians, and feminist activists to let the matter die. But at Minnesota, the forceful responses by Friedman and the general counsel, Mark Rotenberg have successfully silenced internal dissent at the university.

This silence is understandable, but unfortunate. The issues at stake go well beyond the death of Dan Markingson. If more research deaths are uncovered, will the faculty at the University of Minnesota be able to say, “We did all we could to prevent them”?

Carl Elliott is the author of White Coat, Black Hat: Adventures on the Dark Side of Medicine. Elliott is a professor at the Center for Bioethics at the University of Minnesota. His work has appeared in The New Yorker, Atlantic Monthly, the Believer, Slate, the London Review of Books, and theAmerican Prospect. His six previous books include Better Than Well, Prozac As a Way of Life, Rules of Insanity, and A Philosophical Disease.

In June, I will be returning to Washington for the annual Pharmed Out conference, a project located at Georgetown University Medical Center. It is one of my favorite events of the year, in part because of the wide array of academics, journalists, and activists who attend, but mainly because of its extraordinarily committed, outspoken director, Dr. Adriane Fugh-Berman, and her merry band of student volunteers. Adriane agreed to an interview by email.

Would it be fair to say that your project was funded by a felony?

Yes, we were funded by the Attorney General Consumer and Prescriber Grant program, a novel and never-to-be-repeated program that resulted from a settlement between Pfizer and all 50 states and the District of Columbia. We promised so much that before we got the grant, the grant administrators asked us to cut down what we promised to do. We refused — and in the end, we exceeded what we promised.

Just by chance, we had begun our project by shooting an interview of Shahram Ahari — a former drug rep for Eli Lilly who is now a medical student — talking about how he had sold Zyprexa. That was just days before the story broke in The New York Times about how Lilly hid data about adverse effects. Jim Ridgeway, the investigative reporter and filmmaker we worked with, realized that what we had was newsworthy and insisted that we release a quickly edited video clip. We didn’t even have a phone line yet, let alone a Web site. So we released the video on YouTube, crediting the not-yet-existing PharmedOut, with Georgetown’s media office as the contact number. It received a lot of media attention. The video “Zyprexa Drug Rep” has been viewed more than 150,000 times.

Since then, we’ve done novel research on, for example, promotional tone in medical journal articles, and how marketing messages are inserted into CME. We created the first educational module that has convinced physicians that they are personally affected by promotion. And we’ve had groundbreaking conferences, the third of which will be held at Georgetown on June 14-15. It’s called “Missing the Target: When Practitioners Harm More Than Heal,” and will cover the potential adverse effects of marketing drugs and medical devices.

How did you get started as an activist?

I came out of women’s health advocacy work, and we were fighting medicalization of childbirth, menopause, and menstruation, so I feel I always had that bent. Being a reformer suits my crabby nature.

I come from a family of utterly fearless women. I’m the most cautious, but apparently still less afraid than most. My parents were both anti-Vietnam war activists. My mother was very active with Women’s Strike for Peace, and met with Vietnamese women in Djakarta. My brother was president of SDS [Students for a Democratic Society] at Rutgers. I think I learned to walk at demonstrations.

I got involved in feminism, women’s health, worked at Planned Parenthood as a teen, then a reproductive health clinic as a counselor and medical assistant. I would sometimes ask docs to treat women who couldn’t afford care. I decided it would be easier to become a doc then beg docs to help people. Anyone who hasn’t been through medical training romanticizes medicine; med school and internship were so tough in unexpected ways.

I know exactly what you mean, but maybe you should explain.

Med school was anti-intellectual and inhumane. First there was the vast quantity of mind-numbing rote memorization of largely irrelevant material in the basic-science years, followed by the clinical years, in which we learned tradition, myth, and ritual. The overwhelming amount of material in the preclinical years makes students pine for shortcuts. No wonder they’re ripe for the simplistic, definitive messaging of drug reps later. Third year was one long hazing ritual; then in fourth year we were accepted into the fold. And in gratitude, we would accept and perpetuate the whole dehumanizing training system.

Questions were punished. Empathy for patients was discouraged. I was horrified that there seemed to be no connection between medicine and public health, and only a tenuous connection between medicine and science. (Whenever docs are caught out doing something nonscientific, they say, medicine is an art, not a science.) And only lip service was paid to the concept of patient autonomy, or making medical decisions in the context of a patient’s own life and values.

So when they removed your soul in medical school, did it hurt? I was under the impression that soul extraction was a pretty simple procedure, but to be honest, I found it excruciatingly painful.

Yeah, they need to work on the informed consent for that procedure.

I think all of us found ourselves doing things or thinking things we would not have imagined being capable of. Being deprived of sleep, food, and the company of loved ones is terrible for the soul. I remember reading an account of a hungry, exhausted intern who wolfed down the dinner of a patient who had just died. No physician would be proud of that, but we would all understand it. We need to change the training system. Physicians-in-training who are treated compassionately will treat their patients with compassion. Medical training is changing, but not fast enough.

Can you think of any particularly bad moments that seem emblematic to you?

The interns discussing how we envied patients because they were lying in bed and eating and watching TV. It’s terrible looking back on how distorted our thinking was. One of my internship mates ended up in a mental institution; another intern attempted suicide. Standing in a supply cabinet looking for a kit to cath someone who hadn’t peed in 18 hours and realizing, “Hey, I haven’t peed in 18 hours either.” On a psych rotation, handing out an account of a patient permanently damaged by electroconvulsive treatment to fellow students and having them hand it back, saying, “I don’t want to hear the other side if it involves more reading.” Being criticized for putting my arm around a pregnant teen on the way to the exam room. Realizing that preference in IV fluids or antibiotics varied by medical specialty as opposed to patient or disease characteristics. The utter exhaustion — falling asleep on a bus to my clinic for four hours, as the bus crisscrossed the Bronx. The guy I lived with didn’t make it home one night because he fell asleep on a dumpster at a subway station.

What about your writing? When did that start, and how?

I always wrote. I come from a family of writers and activists. Words were important. My father was a professor working on his fourth book on American government when he died at age 39. My mother wrote as well — a column for a small newspaper, letters to the editor. She would have written more had she not been left widowed and penniless with a nine-year-old and a 19-year-old. She never finished a cookbook she started, but my brother, a chef, later wrote one. I was made to write letters as a child, and my family wrote letters to each other. I remember coming home once to an eight page screed from my mother unfurling from a kitchen cabinet.

Anyway, my mother went into the restaurant business, which she ran like a social-service agency. She hired a busboy too damaged to speak, poor single mothers, a prostitute from Chinatown. She brought in chefs from China. Our restaurant launched many others in DC. She was so generous to everyone. We never had money, but we had lots of fun and ate like kings. Food, in my family, was the most important thing. My grandmother believed you should be able to recreate any dish you taste. Not that she deigned to make much non-Chinese food. She did make a great apple pie, from sour, quarter-size apples from a tree in her backyard. I didn’t realize that she had learned to make apple pie in some YWCA American acculturation course she took after coming to the U.S.. As a child I thought apple pie was a Chinese dish. The day my grandmother made a bad dish was the day we knew she was dying.

How have you managed to keep Pharmed Out going?

Those of us who started the project came out of nonprofit groups so we knew how to work crazy hours, convince volunteers to work harder for free than they ever worked for pay, and stretch a penny until it screams. We have an incredibly smart, savvy, responsive, creative team.

Our strength has always been the industry insiders who have provided us invaluable information on marketing practice, and the utter dedication of the doctors, scientists, students, artists and all the individual donors — who have kept the project going despite our having no external funding support since 2008. Every single person whom I paid off the initial grant continued to volunteer for the project after the money ran out. Our Web master supported the site for years; every academic stayed on. Even our work-study student continued to work for free after our funds ran out. Our fabulous anonymous team is what makes this project great. Because so many team members — not just industry — must remain anonymous, we made a decision not to name those team members who could be named. Our staff has been phenomenal. Alicia Bell, now a med student at the Medical College of Virginia, was the founding staff-person who became an amazing colleague over our first four years; without her we would not have achieved the impact we did. Beth Johnson and Nicole Dubowitz have also been great. But every one of our projects is a team effort. As director, I get way too much credit. I have a brilliant, efficient team that reminds me often of one of my mother’s favorite quotes: “The difficult with ease, the impossible with time.”

A couple of years ago, Beacon Press published White Coat, Black Hat: Adventures on the Dark Side of Medicine, a book that Lauren Slater recommended as "required reading for anyone who has ever been a patient—in other words, for everyone." In WCBH, author Carl Elliott skewers drug-industry reps, exposes how Pharma companies ghost-write "scientific" research studies in support of their products, and introduces us to the world of human guinea pigging--a "career" path for those desperate enough to serve in drug study after drug study in exchange for mediocre pay and few benefits.

Carl sent me an email this week to tell me he had just returned from the Tribeca Film Festival, where he had attended screenings of Off Label, a new film "for which my writing is given credit as the inspiration." He put me in touch with filmmakers Michael Palmieri and Donal Mosher, and I spoke with them via Skype as they were getting ready to leave New York. If you're familiar with WCBH and Carl's other writing in The New Yorker, Mother Jones, The Chronicle's Brainstorm blog, and elsewhere (including Beacon Broadside), you will certainly recognize the themes and people in the film. If you haven't read the book yet, get to it! And keep an eye out for screenings of Off Label. --Jessie Bennett, Blog Editor

Jessie Bennett: What is Off Label about?

Michael Palmieri: It's a film that examines the medicated margins of American society, and it does that initially through human guinea pigs. But it's personal stories of these people, so we're interested in the personal ramifications of the pharmaceutical culture that we live in, and how we're all sort of implicated in that process.

JB: How did you come to make a film about human guinea pigging?

MP: We were showing a rough cut of our first film, October Country, at a film festival in late 2008, and these two producers--Anish Savjani and Vincent Savino, who we ended up working with--they saw the film and they followed up with us and said, "Hey, would you guys be interested in making a film about human guinea pigs? " And we said, "Yeah, sure, maybe. It sounds interesting..."

Donal Mosher: And they said they had money.

MP: Yeah, they said they had money, and we said, "Okay, sure!" They actually did have a budget to make it, and it was an intriguing subject, but we didn't know if it could become a whole film. It seemed to us initially like a 60 Minutes-length, investigative reporting piece more than what we're interested in doing, which is a broader view of a subject or a viewing from sort of left field. But the first articles they showed us were Josh McHugh from Wired magazine ["Drug Test Cowboys: The Secret World of Pharmaceutical Trial Subjects"] as well as Carl's article called "Guinea-Pigging" [The New Yorker], which we really latched on to. We really liked the way he wrote the piece. So we ended up contacting him and discussing what we were doing, and he gave us more leads, more information. We eventually ended up meeting him. It kind of developed organically from there. "Guinea pigs" was the initial interest, but then we expanded the idea once we understood on a deeper level what was going on that was somewhat suspect in the guinea pigging world. If the testing is messed up, then what's messed up about the marketing? And what are the end results?

DM: We also began to see how the issue didn't just lie in the zone of the issue itself, but it was pervasive. Every time we'd have a conversation with someone, they had a relative or they themselves were on pharmaceuticals. And the stories were multiplying in a way that made us think this is an issue that pervades many layers of culture far beyond medicine or taking medicine itself. So we wanted to start working those ideas into the film.

JB: Who were some of the subjects that you spoke with? I recognized a few of the characters from Carl's writing.

DM: Originally we spoke with Bob Helms [of Guinea Pig Zero]. A lot of the well-known names in the human guinea pig scene, the people who are testing the drugs. And then from there, we moved on to Mary Weiss, who is also in Carl's writing.

MP: Robert Helms was in the original article that Carl wrote for the New Yorker. So we contacted him and spent time with him, and while we were in Philadelphia, Donal had initiated contact with a writer who had written a book called Acres of Skin, which gave us Eddie Anthony's story. He was an inmate in a prison at Holmesburg when it was actually legal to conduct medical testing on prisoners. And it really screwed up his life because some rough tests occurred when he was in there. We had initiated contact with Paul Clough through his website [Just Another Lab Rat]. Paul is based in Austin, but he has a website very much like what Robert Helms has with his fan zine Guinea Pig Zero, set up for people in the guinea pigging community to speak with one another and share. "Oh, this test actually pays good money." "These people have terrible food." It's kind of amazing, because these people are doing this for a living.

JB: This is the thing that really shocked me about White Coat, Black Hat. "There's a human guinea pigging community?"

MP: And beyond that, it's a community of people who have no... there's no health plan for them. They're doing this because they don't have any other option. But for us, we could clearly understand that the testing is somewhat dubious on certain levels. I mean, obviously we need tests, there's a lot of positive, real things that come out of that testing. But people are lying to get into studies, and it's not exactly as clean of a population study as you would think it is. So the results are going to be skewed. Once we saw, "Okay, skewed results," we started moving more towards marketing, and we were introduced to [former pharmaceutical representative] Michael Oldani, through Carl. Again. Which is why, in a certain sense... how did we say it now? Not dedicated...

DM: "Inspired by."

MP: The film is truly inspired by Carl's writing. It's not just the characters that he led us towards, of which I think he led us toward five of the eight characters. But it's the endless numbers of hours spent with him in Minneapolis. At a coffee shop, where we would meet to discuss something, and we'd look at our watches and eight hours had passed. It's the types of conversations you dream to have all the time. We just got to know each other really well, and his style of writing is so expansive, and it moves from one idea to the next idea. He's such a big brain on a stick, you know what I mean? We wanted to try to do something like that with this film, that followed a line of reasoning as opposed to a specific plot. As a means to take in all of the complications of the issue that we were examining. But rather than having it point a finger at pharma and say, "This is the bad guy, and this is the problem." Which is the "call to action" documentary. We wanted to make a film that was a call to reflection, which is what Carl's writing is like, or the feeling at least that we got from it.

JB: Mary Weiss, the mother of the test subject who died in Minnesota, who Carl writes about in WCBH, is featured in the film. Can you tell us about her story?

DM: In short, she attempted to get her son into a mental hospital. And when she couldn't, she found him space at the University of Minnesota. At first, he was assessed that he couldn't make any rational judgment about his own medication--that he wasn't sane enough. And then, within twenty-four hours, that was reversed. The full details of the story are in an article that Carl wrote for Mother Jones, but essentially it was a doctor who placed his own psychiatric patient in a very lucrative testing study. Not a study testing the efficacy of the drug that was prescribed for this young man, but a comparison marketing study where the dosage was fluctuating. The result was an incredibly sad and grisly suicide. From that point on, his mother has been fighting to change Minnesota laws, and to make those changes nationally.

MP: And to clarify, this happened at the University of Minnesota, where Carl works. And the study that Dan Markingson was entered into was not only a marketing study, but it was a study that was conducted by the same doctor who was his attending physician. So the conflict of interest was so obvious in this case, but it was still legal. So Mary Weiss has helped pass the law to make that illegal.

JB: You just finished up at the Tribeca Film Festival. How did it go?

MP: It went great. We showed the film four times. We finished yesterday, and the screenings were all pretty full. Carl was there for the first two screenings, with a couple of other people from the film. We are kind of thrilled with the response. It's gotten some fantasticreviews as well. So we're really happy.

JB: How was the audience reaction to the film in Tribeca?

MP: I usually read it from the perspective of, "How many people left during the credits who didn't want to stick around for the Q&A?" An overwhelming number of people stuck around, which was a good sign to begin with, but the questions, they kept coming until they had to kick us out of the theater. So people are, I think, really engaged with the film. Everyone seems to be invested, so we're really happy. And if it causes people to pause and think about what medicine is going inside their bodies, I think we have succeeded, at least on that level, and it makes us very happy.

JB: And where are you headed next?

MP: We're headed to HotDocs in Toronto, where the film is premiering internationally. The Toronto documentary crowd is insanity. We've already sold out most of our screenings, and they're gigantic places. We're looking forward to that. And we're hoping that there's a lot of European interest in screening the film.

JB: Well, it's an international issue.

MP: But it's a very American film, so we're curious to how Europe responds.

DM: We're really curious to see, when there's an international audience, what stories they give us about the situation in whatever country the film might land.

Carl Elliott is the author of White Coat, Black Hat: Adventures on the Dark Side of Medicine. Elliott is a professor at the Center for Bioethics at the University of Minnesota. His work has appeared in The New Yorker, Atlantic Monthly, the Believer, Slate, the London Review of Books, and the American Prospect. His six previous books include Better Than Well, Prozac As a Way of Life, Rules of Insanity, and A Philosophical Disease.

If Texas ever decides to secede from the Union, I’d be mighty tempted to go along. Lightnin’ Hopkins, Molly Ivins, Bob Wills, Kinky Friedman, the 1966 Texas Western basketball team: Without the Lone Star State, American life would look pretty anemic. When Steve Earle declared, “Townes Van Zandt is the best songwriter in the whole world and I’ll stand on Bob Dylan’s coffee table in my cowboy boots and say that,” I nodded and said, “Amen.”

Most of all, I like Texas crazy. There is no better value for your entertainment dollar. As a native South Carolinian, I claim some expertise in the topic. My brother says: What Mississippi is to the poverty index, South Carolina is to the index of crazy people. (Our unofficial state motto, provided by James L. Petigru in 1860: “South Carolina is too small to be a republic, and too large to be an insane asylum.”) For many years now, my Texan friend Kathryn Montgomery and I have had a contest over which state has a higher proportion of crazy people, and for many years, thanks to our remarkable politicians, South Carolina has been flat-out killing it. Over the last few months, however, Texas may have pulled ahead.

The reason is stem-cell tourism. It started when Gov. Rick Perry had a surgeon friend treat his back problems with adult stem cells processed by RNL Bio, a South Korean company famous mainly for its commercial puppy cloning business and “cosmeceutical” preparations such as Dr. Jucre’s Million Stem Cell Magic Concentrate (available online for $1,220.) Pretty soon an entire stem-cell operation called Celltex Therapeutics was up and running, partnered with RNL Bio and backed by a group of Texas oil and gas investors. Unfortunately for the company, there has been a minor bump in the road called “medical research.” Reputable stem cell researchers say there is little medical evidence to show that adult stem cells are effective for the conditions they are supposed to treat (which, according to a RNL Bio spokesperson, range from wrinkles to Alzheimer’s disease). Even worse, the cells may be dangerous. As Paul Knoepfler, a stem cell researcher at UC Davis pointed out recently, “The worst case scenario, even for autologous transplant, is death. The second worse case scenario is severe, life-changing injury.”

You don’t need a marketing degree to understand that “death” and “severe, life-changing injury” are not going to sell a lot of stem cells. So those words don’t appear in the patient testimonials RNL Bio uses to market its services. In fact, the stem cell treatments are illegal in South Korea, where RNL Bio is based, so the company partners with facilities in other countries such as China and Japan to exploit regulatory loopholes. Patients with debilitating chronic illnesses can travel to those countries for stem-cell treatment. Last week, we learned from Nature that Texas has joined that list of countries. A Houston doctor told a Nature reporter that he is paid by Celltex to give adult stem-cell treatments to patients with multiple sclerosis and Parkinson’s disease, who may be charged up to $25,000.

A few months ago, I had reason to hope that South Carolina might be making a comeback in the craziness sweepstakes. An assistant professor at the Medical University of South Carolina was arrested by the FBI for supplying adult stem cells to an illegal operation in Mexico. But my hopes fell when I read the FBI press release. His co-conspirators, unfortunately, were from Texas.

Carl Elliott is the author of White Coat, Black Hat: Adventures on the Dark Side of Medicine. Elliott is a professor at the Center for Bioethics at the University of Minnesota. His work has appeared in The New Yorker, Atlantic Monthly, the Believer, Slate, the London Review of Books, and the American Prospect. His six previous books include Better Than Well, Prozac As a Way of Life, Rules of Insanity, and A Philosophical Disease.

The pharmaceutical industry gets a bad rap. To listen to the critics you’d think pharmaceutical companies are in the same sleazy category as oil, finance and tobacco companies. But pharmaceutical companies invent life-saving medications, not to mention countless other psychoactive products that many of us enjoy on a recreational basis. Pharmaceutical companies get blamed for fraud, kickbacks, and research deaths, but they never get the credit for oxycontin.

That is why I was thrilled to see that GlaxoSmithKline is sponsoring the prize for the British Medical Journal's annual Research Paper of the Year. Sure, the pharma-bashers will whine like infants at the BMJ’s decision to brand a medical research prize with the name of multinational drug company, just as they’re whining about an American editor’s decision to re-locate a leading bioethics journal to the Texas headquarters of a stem cell tourism clinic. These people just don’t get it. This is not about propaganda or corruption. It is about developing innovative medications for diseases that we didn’t even know existed.

In that spirit, my nomination for the GlaxoSmithKline (GSK) Research Paper of the Year goes to a ground-breaking article about GSK’s very own antidepressant, Paxil, which was published in the Journal of the American Academy of Child and Adolescent Psychiatry. The title of the article is “Efficacy of Paroxetine in the Treatment of Adolescent Major Depression,” but seasoned pharma-watchers know it better as Study 329. The data behind Study 329 showed that Paxil didn’t actually work in adolescents – that, in fact, it was no better than a sugar pill. However, as any marketer understands, bad data cannot be allowed to interfere with a good paper. By the time Study 329 appeared in print, GSK had used the magic of biostatistics to transform the raw data into a gleaming advertisement for Paxil. As a result, when FDA eventually decided that Paxil had a few minor side-effects, such as suicide, Study 329 had already done its work: getting a GSK product into the hands of troubled teenagers. And wait, here’s the beauty part: although the published version of Study 329 was “authored” by leading academic psychiatrists, it was actually written by a GSK ghostwriter.

Of course, the pharma-bashers have been complaining about Study 329 for years. Some of them even want the journal to retract it. The lead “author” who signed the paper, Martin Keller of Brown University, has been beaten up by the Senate Finance Committee, harassed by the New York attorney general, and vilified in the press, all because he put his name on a ghosted article and forgot to report half a million dollars in pharmaceutical income. To which I say: stand strong, GSK. Ignore the naysayers and the nitpickers. It’s about time you gave these good people some public recognition. Yes, it’s true that Study 329 is eleven years old, but you’re paying the BMJ over $47,000 tosponsor this prize. Surely they can bend the rules, just this once.

Carl Elliott is the author of White Coat, Black Hat: Adventures on the Dark Side of Medicine. Elliott is a professor at the Center for Bioethics at the University of Minnesota. His work has appeared in The New Yorker, Atlantic Monthly, the Believer, Slate, the London Review of Books, and the American Prospect. His six previous books include Better Than Well, Prozac As a Way of Life, Rules of Insanity, and A Philosophical Disease.

A number of years ago, a university public-relations official approached me with an invitation. Her office was coordinating a series of columns called “Health Talk and You,” which were published in about 50 newspapers around the state. The columns were short, simple, and straightforward – about 500 words, she said. Would I be interested in taking part? Without giving the question much thought, I said yes.

Then I read her email more carefully. I had initially thought I was being asked to write an article. In fact, however, I was being asked to lend my name to an article which the public relations office would ghostwrite, but which would be published under my byline. A reporter would interview me on the topic of my choice and write an article based on the interview. When I called the public relations officer back, I explained that it seemed deceptive to take credit for an article that I didn’t actually write. She bristled; the conversation turned chilly; and by the time we hung up, we had both agreed that I would make a very poor “author.”

Given how badly that brief conversation went, it was probably best that I didn’t mention my other reservation about the article. What bothered me was not just the deception. I was also afraid someone might think I had actually written the kind of embarrassing propaganda and mindless fluff typically generated by a public-relations office. Seeing that column appear in a newspaper under my name would have been like watching myself recite the prepared text in a hostage video.

Don’t get me wrong. I don’t have a problem with fakery, given the right circumstances. I can read a ghosted celebrity autobiography with the same pleasurable suspension of disbelief with which I watch professional wrestlers. It’s just that I never really thought of the university as the aesthetic equivalent of the World Wrestling Federation.

Of course, it is possible that I overreacted. After all, the ghosted columns had been appearing for years, presumably under the names of other faculty members. Maybe my colleagues simply put the columns in the same category as the throwaway newsletters, promotional flyers, annual reports and spam email generated by administrative offices all over the university. Nobody even reads that material, much less worries about its provenance. Or maybe they thought the columns were like speeches delivered by university presidents or high-ranking deans, which most of us simply assume to be written by a ghostwriter. “Bureaucratic plagiarism” is the term used by Gavin Moodie to describe this kind of fuzziness around authorship, and as he points out, it raises an uncomfortable question. If we don’t allow university students to hire ghostwriters, why do we allow it for university administrators?

When plagiarism lands an administrator in trouble, it is usually plagiarism of the more familiar variety. Last summer, for example, Philip Baker, the Dean of the Faculty of Medicine and Dentistry at the University of Alberta, delivered a convocation speech that was lifted — word for word, according to medical students following on their smartphones — from a Stanford University commencement address by Harvard surgeon and New Yorker staff writer, Atul Gawande. Baker was eventually forced to resign.

Simply employing a ghostwriter, however, is often not seen as a problem — unless the ghostwriter is also a plagiarist. In 2007, for example, when several newspaper columns published by William Meehan, the president of Jacksonville State University, were found to contain material plagiarized from various websites, his excuse was that the columns had actually been ghosted by the director of the university news bureau. (Meehan was later accused, apparently with credible evidence, of having plagiarized parts of hisdoctoral dissertation.) Similarly, when the president of Wesley College, Scott D. Miller, was accused of plagiarizing sections of a speech written by the president of Connecticut College, he told reporters that he had “a number of people who do some drafting for me.” Miller said, “I don’t remember the specifics of who wrote it.”

Of course, paying a ghost to write your speeches is not like paying a ghost to write your doctoral dissertation or your academic articles. Neither is rubber-stamping an administrative document produced by an assistant. As Brian Martin has pointed out, bureaucratic plagiarism (or what he calls “institutionalized plagiarism”) is standard practice in many large, hierarchical organizations, where well-paid, high-status leaders take credit for written material produced by others who rank below them on the organizational ladder. University administrators sometimes compare themselves to corporate executives, who are not generally criticized for having ghostwriters on staff. But administrators, of course, are not executives. Most of them are tenured members of the faculty. Should they be judged by the norms and standards of corporations? Or should they be judged by the standards usually applied to faculty and students?

Of course, administrators could not really be expected to produce such a vast amount of written material without a small army of “communications professionals.” Yet, as Benjamin Ginsberg argues in his excellent book, The Fall of the Faculty: The Rise of the All-Administrative University, all this written material is subsidized by student tuition, which continues to rise dramatically. Wouldn’t the budget for university-subsidized ghostwriters be a good place to start cutting? Also, paying ghosts to write for senior administrators seems unfair to the rest of us. As Ginsberg says, “faculty members who plagiarize must do so at their own expense.”

Beacon Press author Carl Elliott has been under attack in a scenario best described by one of his many defenders as “Orwellian.” In order to defend academic freedom, his university argues, they must prevent him from speaking.

Please read some of these posts to learn more about this important (and disturbing) story. -- Helene Atwan, Beacon Press Director

Over the past twenty-five years, the practice of medicine has been subverted by the business of medicine, sacrificing old-style doctoring to fit the values of consumer capitalism. InWhite Coat, Black Hat: Adventures on the Dark Side of Medicine, physician and moral philosopher Carl Elliott traces for the first time the evolutionary path of this new direction in health care, revealing the dangerous underbelly of the beast that has emerged. We're introduced to the often shifty characters who work the production line in Big Pharma: the professional guinea pigs who test-pilot new drugs; the ghostwriters who pen "scientific" articles for drug manufacturers; the PR specialists who manufacture "news" bulletins; the drug reps who will do practically anything to get their numbers up; the "thought leaders" who travel the world to enlighten the medical community about the wonders of the latest release; even, finally, the ethicists who oversee all this from their pharma-funded perches.

Check out Carl Elliott's recent clinical trial expose in Mother Jones, and his piece on Big Pharma's Thought Leaders in the Chronicle Review.